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Search / Trial NCT07066267

Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Launched by SUNKAKY MEDICAL COOPERATION · Jul 4, 2025

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Mitochondria Mitochondria Transplantation Adipose Stem Cell Oocyte Female Infertility

ClinConnect Summary

This clinical trial is exploring a new way to help women who have had several unsuccessful attempts with in vitro fertilization (IVF). The study looks at whether adding healthy energy-producing parts of cells, called mitochondria, taken from a woman’s own fat tissue, to her eggs can improve the quality of embryos and increase the chances of a successful pregnancy. This approach is combined with a common IVF technique where a single sperm is directly injected into an egg. Since egg quality often affects embryo development and pregnancy success, especially in women of advanced age or those with repeated IVF failures, this study aims to see if boosting the egg’s energy can make a difference.

Women who might join this study are those who have tried IVF at least three times without success, don’t have major problems with their uterus or ovaries, and have a body mass index (BMI) under 26. Participants will need to agree to specific steps, such as having a small sample of fat tissue taken through a minor procedure, freezing all embryos created, and performing tests on the embryos before transferring one back to the uterus. The study excludes women with certain medical conditions affecting the ovaries or uterus, severe sperm problems, or other health issues that could affect treatment. If you join, you can expect careful monitoring through the IVF process, additional tissue collection to support the treatment, and detailed testing to help improve your chances of pregnancy.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Having at least three previous failed IVF trial
  • Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis
  • Specifically consented for to have single blastocyst transfer (recommended)
  • No major uterine or ovarian abnormalities
  • Specifically consented for to have all embryos frozen
  • Specifically consented for to collect adipose tissues from subcutaneous liposuction
  • BMI level level \<26kg/m2
  • Exclusion Criteria:
  • Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4
  • Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections
  • Severe sperm abnormalities
  • \<5 million/mL motile sperm
  • Uterine structural anomalies
  • Polycystic ovaries
  • Premature ovarian failure

About Sunkaky Medical Cooperation

Sunkaky Medical Cooperation is a dedicated clinical trial sponsor committed to advancing medical research and enhancing patient care through innovative therapeutic solutions. With a focus on developing cutting-edge treatments across various therapeutic areas, Sunkaky Medical Cooperation collaborates with healthcare professionals, regulatory bodies, and research institutions to ensure the highest standards of clinical trial design and execution. Our mission is to facilitate the discovery of safe and effective medical interventions that address unmet needs, ultimately improving health outcomes and quality of life for patients worldwide.

Locations

Colombo, , Sri Lanka

Patients applied

0 patients applied

Trial Officials

Dr. Helaruwan Pasan Kumara WA, MD, PhD

Principal Investigator

Wish Fertility Hospital Pvt. Ltd

Prof. Yoshiharu Morimoto, MD, PhD

Principal Investigator

Horac Grand Front Osaka Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported